Chronic HCV HepatitisPhase 3EGG-18NCT03496233
Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients
A Phase 3 study testing Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier] in people with Chronic HCV Hepatitis, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
Trial summary
Antiviral treatment of G1b Treatment-Naïve HCV-Infected Patients, with non- severe fibrosis, with or without insulin resistance (IR) and/or diabetes mellitus (DM) with EBR/GZR Fixed-Dose Combination for 8 Weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic HCV Hepatitis
- What is being tested?
- Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteItaly
- Study dates
- 19 Sep 2018to 20 Jun 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
- Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
- Non severe fibrosis (F≤ 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest® lower than 0.59 or Fibrometer® lower than 0.63 if Fibroscan® cannot be performed.
- Patients who are HBV core antibody positive. These patients should be monitored for hepatitis flare or HBV reactivation during HCV treatment and post treatment follow-up. Appropriate patient management for HBV infection as clinically indicated should be initiated as recommended by the European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol (2017).
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- Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to enrollment
- Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use 2 effective method(s) of contraception from at least two weeks prior to Day 1 through 14 days after the last dose of study drugs.
- A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subjects who is not of reproductive potentials is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation.
- A male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
- Lactating females must agree to discontinue nursing before starting study drug
- Subject must be of generally good health, with the exception of chronic HCV infection, and glucose abnormalities as determined by the Investigator
- Subject must be able to comply with the dosing instructions for study drug administration
Who cannot join
- Is under the age of legal consent, is mentally or legally incapacitated, has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Current or prior history of any of the following:
- Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
- Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- History of decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
- Solid organ transplantation (including hematopoietic stem cell transplants) other than kidney, cornea and hair.
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- Significant cardiac disease
- Unstable psychiatric condition including hospitalization, suicidal attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
- Malignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible
- Significant drug allergy (e.g., hepatotoxicity)
- Subject has the following laboratory parameters at Screening:
- ALT > 10 x the upper limit of normal (ULN)
- AST > 10 x ULN
- Direct bilirubin > 1.5 x ULN
- Platelets < 75,000/μL
- Creatinine clearance < 50 mL/min as calculated by the Cockcroft-Gault equation
- Hemoglobin < 10 g/dL
- Albumin < 3 g/dL
- INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regime affecting INR
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Infection with human immunodeficiency virus (HIV)
- HBsAg positive patients
- Clinically-relevant alcohol or drug abuse within 12 months of Screening.
- Use of any prohibited concomitant medication listed in the specific SmPC section.
- Known hypersensitivity to the study drug, the metabolites, or formulation excipient
- Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study.
- (female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria); or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria).
- had a life-threatening SAE during the screening period.
- is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
- has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
- For subjects diagnosed with diabetes mellitus, documented HbA1c >8.5% (to exclude uncontrolled diabetes)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients With Non-severe Fibrosis, With or Without Glucose Abnormalities - EGG 18"
Antiviral treatment of G1b Treatment-Naïve HCV-Infected Patients, with non- severe fibrosis, with or without insulin resistance (IR) and/or diabetes mellitus (DM) with EBR/GZR Fixed-Dose Combination for 8 Weeks.
Read the detailed description
Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Seventy-five (75) treatment-naïve subjects with chronic HCV GT1b infection (without cirrhosis) with or without glucose abnormalities such as insulin resistance and or diabetes will be consecutively enrolled.
The investigators decided to include also patients with glucose abnormalities at baseline screening since data on these patients are scanty, and inclusion of this subgroup of patients better reflects the clinical practice. The study will consecutively enroll patients, without fixing a specific rule (e.g. sample allocation ratio) for recruitment of patients with and without glucose abnormalities. This will allow to evaluate the proportion of patients with and without glucose abnormalities at baseline (a useful approach to understand the impact of patients with glucose abnormalities in real life) and to perform explorative analyses to compare patients with or without glucose abnormalities according to SVR.
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily without regards to food.
- Conditions
- Chronic HCV Hepatitis
- Being tested
- Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]Drug
Treatment with EBR/GZR Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients, with non- severe fibrosis, with or without IR and/or DM
| Study group | Role | What they receive |
|---|---|---|
| All patients included | Experimental | All patients included will be treated with Elbasvir/grazoprevir for 8 weeks Receives: Drug: Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of elbasvir/grazoprevir fixed dose combination for 8 weeks in genotype 1b treatment naive HCV infected patients.
Proportion of subject with sustained viral response (SVR) 12 weeks after cessation of treatment in G1b treatment naive HCV infected patients, with non severe fibrosis, with or without IR and/or DM treated with elbasvir/grazoprevir fixed dose combination for 8 weeks.
Measured: at 12 weeks
Secondary outcomes (2)
Incidence of treatment emergent adverse events (safety and tolerability).
Number (percentage) of participants with treatment related adverse events.
Measured: 12 weeks after cessation of treatment
Insulin resistance
- Assessments of insulin resistance were measured using HOMA-IR at baseline and follow-up week (FW)12
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start19 Sep 2018
- Primary completion20 May 2020
- Study completion20 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic HCV HepatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Craxi, Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496233
- Sponsor's protocol ID
- 2017- 003710 -58
- Other IDs
- 2017
- Acronym
- EGG-18
- Status last verified
- Feb 2023
- First submitted
- 16 Feb 2018
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients With Non-severe Fibrosis, With or Without Glucose Abnormalities - EGG 18"
- ClinicalTrials.gov ID
- NCT03496233
- Acronym / sponsor ID
- EGG-18 / 2017- 003710 -58
- Conditions
- Chronic HCV Hepatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone PalermoUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 20 Jun 2020 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Antiviral treatment of G1b Treatment-Naïve HCV-Infected Patients, with non- severe fibrosis, with or without insulin resistance (IR) and/or diabetes mellitus (DM) with EBR/GZR Fixed-Dose Combination for 8 Weeks.
Detailed description
Study Type: Interventional Study Design: Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Seventy-five (75) treatment-naïve subjects with chronic HCV GT1b infection (without cirrhosis) with or without glucose abnormalities such as insulin resistance and or diabetes will be consecutively enrolled.
The investigators decided to include also patients with glucose abnormalities at baseline screening since data on these patients are scanty, and inclusion of this subgroup of patients better reflects the clinical practice. The study will consecutively enroll patients, without fixing a specific rule (e.g. sample allocation ratio) for recruitment of patients with and without glucose abnormalities. This will allow to evaluate the proportion of patients with and without glucose abnormalities at baseline (a useful approach to understand the impact of patients with glucose abnormalities in real life) and to perform explorative analyses to compare patients with or without glucose abnormalities according to SVR.
There will be one treatment group with EBV/GZR (50/100 mg) once daily without regards to food for 8 weeks.
EBV/GZR is manufactured as a 50/100 mg tablet for oral administration. Subjects will take 1 tablet daily without regards to food.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients included | Experimental | Drug: Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]All patients included will be treated with Elbasvir/grazoprevir for 8 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years
- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
- Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
- Non severe fibrosis (F≤ 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest® lower than 0.59 or Fibrometer® lower than 0.63 if Fibroscan® cannot be performed.
Key exclusion criteria (31 listed)
- Is under the age of legal consent, is mentally or legally incapacitated, has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- Current or prior history of any of the following:
- Subject has the following laboratory parameters at Screening:
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- Infection with human immunodeficiency virus (HIV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]Treatment with EBR/GZR Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients, with non- severe fibrosis, with or without IR and/or DM | Drug | All patients included |
Primary outcome
Efficacy of elbasvir/grazoprevir fixed dose combination for 8 weeks in genotype 1b treatment naive HCV infected patients.
Time frame: at 12 weeks
Proportion of subject with sustained viral response (SVR) 12 weeks after cessation of treatment in G1b treatment naive HCV infected patients, with non severe fibrosis, with or without IR and/or DM treated with elbasvir/grazoprevir fixed dose combination for 8 weeks.
2 secondary outcomes
Incidence of treatment emergent adverse events (safety and tolerability).
Time frame: 12 weeks after cessation of treatment
Insulin resistance
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier] in people with Chronic HCV Hepatitis, run by Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of elbasvir/grazoprevir fixed dose combination for 8 weeks in genotype 1b treatment naive HCV infected patients. (time frame: at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2023.